Risk in Vaccine Research and Development Quantified
Risk in Vaccine Research and Development Quantified
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DOI：
10.1371/journal.pone.0057755
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发表时间：
2013-03-20
期刊：
影响因子：
3.7
通讯作者：
Osterhaus, Albertus D. M. E.
中科院分区：
文献类型：
--
作者：
Pronker, Esther S.;Weenen, Tamar C.;Osterhaus, Albertus D. M. E.
迄今为止，疫苗接种是防治传染病最具成本效益的战略。最近，生产力差距影响了制药业。生产率差距描述了一个行业内投入的资源与预期的产品周转率不匹配的情况。虽然已经公布了新化学实体（NCE）的风险概况（结合研发时间表和转换率），但关于疫苗开发的记录很少。目的是计算针对人类传染病的疫苗的风险概况。积极编制了一个数据库，以包括1998年至2009年在临床前开发阶段、临床试验第一、第二和第三阶段直至市场注册的所有疫苗项目。从临床前阶段提取的疫苗平均需要10.71年的开发时间，进入市场的概率为6%。按疾病区域分层显示大流行性流感疫苗目标是有利可图的。此外，与针对慢性感染和治疗用途的疫苗相比，针对急性传染病的疫苗和预防性疫苗具有较低的风险。结论;这些统计数据适用于针对人类传染病的疫苗。针对癌症、过敏和自身免疫性疾病的疫苗需要进一步分析。此外，本文不涉及针对未满足医疗需求的孤儿疫苗，无论项目是授权的还是自行发起的，以及公司的规模和经验。因此，这些变量和其他变量如何影响疫苗风险概况仍有待研究。尽管我们发现疫苗和NCE的风险概况存在巨大差异；在开发时间表方面，疫苗优于NCE。
To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.